Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

Completed · Phase 3

Conditions studied: Psoriasis

In brief

The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Key facts

Study ID

NCT03478787

Run by

AbbVie

People needed

327

Starts

2018-05-08

Expected to finish

2020-07-08

Last updated by the study team

2021-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit
• Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
• Subject must be a candidate for systemic therapy as assessed by the investigator;
• Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.

You may not qualify if…

• History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
• Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
• Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
• History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
• Previous exposure to risankizumab
• Previous exposure to secukinumab

Where it is running

• Alliance Dermatology and MOHs /ID# 204336 — Phoenix, Arizona, United States
• Bakersfield Derma & Skin Cance /ID# 202115 — Bakersfield, California, United States
• Center for Dermatology Clin Res /ID# 202116 — Fremont, California, United States
• Dermatology Res. Assoc., CA /ID# 202170 — Los Angeles, California, United States
• UC Davis Health /ID# 202263 — Sacramento, California, United States
• Medderm Associates /ID# 202162 — San Diego, California, United States
• UConn Health Main /ID# 201745 — Farmington, Connecticut, United States
• Tory P Sullivan, MD PA /ID# 202177 — North Miami Beach, Florida, United States
• Renstar Medical Research /ID# 202113 — Ocala, Florida, United States
• Progressive Medical Research /ID# 202183 — Port Orange, Florida, United States
• Integrated Clinical Research LLC /ID# 202152 — West Palm Beach, Florida, United States
• Dermatology Specialists Resear /ID# 202145 — Louisville, Kentucky, United States
• Dermatology and Skin Cancer Specialists, LLC /ID# 203938 — Rockville, Maryland, United States
• ORA, Inc. /ID# 204342 — Andover, Massachusetts, United States
• Beth Israel Deaconess Medical Center /ID# 204340 — Boston, Massachusetts, United States
• Minnesota Clinical Study Center /ID# 202369 — New Brighton, Minnesota, United States
• Central Dermatology, PC /ID# 202156 — St Louis, Missouri, United States
• Psoriasis Treatment Ctr of Central NJ /ID# 202107 — East Windsor, New Jersey, United States
• Synexus Research Cincinnati /ID# 202161 — Cincinnati, Ohio, United States
• Oregon Derm & Res. Ctr /ID# 201652 — Portland, Oregon, United States
• Oregon Medical Res Center PC /ID# 201651 — Portland, Oregon, United States
• Clinical Partners, LLC /ID# 201736 — Johnston, Rhode Island, United States
• Center for Clinical Studies - Houston (Binz) /ID# 202178 — Houston, Texas, United States
• Progressive Clinical Research /ID# 202155 — San Antonio, Texas, United States
• Advanced Research Associates - Glendale /ID# 204335 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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